Upsilon Global has partnered with a CRO to support an ongoing Cardiovascular Study in Brazil. As part of this collaboration, we are seeking a Regulatory Affairs Specialist to join the team and provide expertise in regulatory activities, ensuring the study progresses in line with local regulations.

Location: Brazil

Study Focus: Cardiovascular Study (Heart Disease Phase II)

Study Duration: 12 months

FTE: 0.5

Key Responsibilities:

• Oversee regulatory compliance for the Cardiovascular Study in Brazil.
• Prepare and submit regulatory documents, including regulatory filings to ANVISA (Brazilian Health Regulatory Agency).
• Manage interactions with regulatory authorities throughout the study lifecycle.
• Coordinate with internal and external teams to ensure all regulatory requirements are met.
• Assist in preparing documents for clinical trial applications (CTAs) and amendments.
• Provide regulatory guidance and support to ensure the study meets both local and international standards.
• Monitor the progress of regulatory submissions and follow up on approval statuses.

Required Qualifications:

• Bachelor’s Degree in Life Sciences or a related field.
• At least 3-5 years’ experience in Regulatory Affairs within clinical trials.
• Knowledge and experience with ANVISA regulations and submission processes.
• Experience working on Cardiovascular studies or within Cardiovascular therapeutics is highly preferred.
• Excellent understanding of regulatory compliance, document preparation, and submissions.
• Strong communication and organizational skills.
• Proficiency in both English and Portuguese.

Please contact Juliana Madiba or call +44 203 875 9966 for more details or to express your interest in this opportunity.